Center for Devices and Radiological Health, U.S. Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, USA.
J Cardiovasc Transl Res. 2010 Dec;3(6):600-3. doi: 10.1007/s12265-010-9225-3. Epub 2010 Oct 29.
The development of ventricular assist devices (VADs) for the treatment of heart failure has been ongoing since the National Heart Lung and Blood Institute (NHLBI) initiated the artificial heart program in 1964. The primary goal was to develop VADs and total artificial hearts for both temporary (short-term) and long-term use. Due to a small target population and the inability to blind patients and clinicians, the Food and Drug Administration (FDA) has recognized the challenges of conducting trials with these invasive devices. In an effort to address those challenges, FDA has accepted a variety of clinical trial designs to collect the data required to evaluate safety and effectiveness data in different patient groups. This article will provide a detailed discussion of the past, present, and future FDA regulatory considerations for VADs.
自 1964 年美国国立心肺血液研究所（NHLBI）启动人工心脏计划以来，用于心力衰竭治疗的心室辅助装置（VAD）的开发一直在进行。主要目标是开发用于短期和长期使用的 VAD 和全人工心脏。由于目标人群较小，并且无法对患者和临床医生进行盲法，美国食品和药物管理局（FDA）已经认识到使用这些侵入性装置进行试验的挑战。为了应对这些挑战，FDA 已经接受了各种临床试验设计，以收集评估不同患者群体的安全性和有效性数据所需的数据。本文将详细讨论过去、现在和未来 FDA 对 VAD 的监管考虑因素。
